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NCT Number: NCT07394842

Longitudinal Oral Health Changes After Head and Neck Radiotherapy

This prospective observational study evaluates how head and neck radiotherapy affects oral health over time. Patients with head and neck cancer undergoing standard radiotherapy are followed from before treatment through multiple post-treatment visits. Changes in periodontal health, dental status, salivary function, and patient-reported oral health quality of life are assessed. The study aims to better understand the long-term oral complications of radiotherapy and to support improved preventive and supportive dental care for cancer patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head & Neck Cancer Carcinoma Carcinoma, Squamous Cell Dental Caries Head & Neck Squamous Cell Carcinoma Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Periodontal Disease Periodontal Diseases Salivary Gland Diseases Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Tooth Demineralization Tooth Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmed Maher Teaching Hospital

Cairo, Egypt

About this study

This prospective longitudinal cohort study investigates the effects of head and neck radiotherapy on periodontal health, dental outcomes, salivary gland function, and oral health-related quality of life.

Adult patients with histologically confirmed head and neck malignancies scheduled to receive external beam radiotherapy are enrolled and followed longitudinally. Clinical assessments are conducted at baseline prior to radiotherapy, at the end of radiotherapy, and at 3, 6, and 12 months post-treatment.

Periodontal evaluation includes clinical attachment level, probing pocket depth, plaque index, gingival index, and bleeding on probing, recorded at six sites per tooth using standardized periodontal examination protocols. Dental outcomes include decayed, missing, and filled teeth index, radiation-associated caries incidence, and tooth mobility. Salivary gland function is assessed using unstimulated whole saliva collection. Patient-reported outcomes include xerostomia severity and oral health-related quality of life using validated questionnaires.

Radiotherapy characteristics including technique, total dose, fractionation schedule, mandibular field involvement, and concurrent chemotherapy are recorded. Longitudinal changes in oral health outcomes are analyzed to identify patterns of disease progression and potential predictors of radiotherapy-related oral complications.

This study aims to generate clinical evidence to improve preventive strategies, early detection, and supportive oral care protocols for patients receiving head and neck radiotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Histologically confirmed head and neck malignancy
  • Planned radiotherapy dose ≥50 Gy
  • Presence of at least 20 natural teeth
  • No periodontal treatment during the preceding 6 months
  • Ability to comply with the scheduled follow-up visits

Exclusion criteria

  • Previous head and neck radiotherapy
  • Autoimmune salivary gland disorders
  • Current bisphosphonate or anti-resorptive therapy
  • Pregnancy
  • Uncontrolled systemic disease (HbA1c >9% for diabetic patients)
  • Severe periodontal destruction requiring immediate surgical intervention

Treatment and study plan

Primary outcomes

  1. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

    Mean change in clinical attachment level measured in millimeters using a standardized UNC-15 periodontal probe at six sites per tooth. CAL is used as the primary indicator of periodontal tissue loss following radiotherapy.

Secondary outcomes

  1. Change in Probing Pocket Depth (PPD)

    Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

    Mean probing pocket depth measured in millimeters at six sites per tooth using a standardized UNC-15 periodontal probe as an indicator of periodontal pocket severity.

  2. Change in Bleeding on Probing (BOP)

    Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

    Percentage of periodontal sites exhibiting bleeding on probing as a measure of periodontal inflammation.

  3. Change in Decayed, Missing, and Filled Teeth (DMFT) Index

    Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

    Dental caries experience assessed using the Decayed, Missing, and Filled Teeth (DMFT) index to evaluate cumulative dental disease burden.

  4. Change in Xerostomia Inventory Score

    Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

    Patient-reported xerostomia severity measured using the validated Xerostomia Inventory questionnaire.

  5. Change in Unstimulated Salivary Flow Rate

    Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

    Unstimulated whole salivary flow rate measured in milliliters per minute using the passive drooling collection method.

  6. Change in Oral Health Impact Profile-14 (OHIP-14) Score

    Time frame: Baseline, end of radiotherapy, and 3, 6, 9, and 12 months post-radiotherapy

    Oral health-related quality of life assessed using the OHIP-14 questionnaire.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Longitudinal Effects of Head and Neck Radiotherapy on Periodontal and Dental Oral Health: A Prospective Cohort Study

Acronym: HN-ORAL-RT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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